Benign Prostatic Hyperplasia Clinical Trial
— AQUAOfficial title:
AQUABEAM® Robotic System and Ultrasound Accessories (AQUA Study)
Lower urinary symptoms (LUTS) affect many older men and their frequency and severity increase with age. In the age group between 65 and 79 years the rate of men with moderate and severe LUTS is 20 - 25% (Hunter et al. 1994). The complaints are potentially associated with a considerable impairment of the quality of life (Trueman et al. 1999). LUTS in older men are commonly caused by a bladder outlet obstruction (BOO) secondary to benign prostatic enlargement (BPE). The histological term "benign prostatic hyperplasia" (BPH) is frequently used in literature and clinical practice as a synonym for this diagnosis. Surgical therapy of BPH has continuously evolved in recent years. One of the latest technologies for transurethral prostate desobstruction is the Aquablation therapy, first described in 2015 (AQUABEAM®, PROCEPT BioRobotics, Redwood Shores, CA, USA) (Faber et al 2015). The AQUABEAM Robotic System is the first and only image-guided, heat-free robotic therapy for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). It is designed for cutting of prostate tissue during a minimally invasive surgical procedure. Once inserted via a transurethral approach and advanced through the urethra and into the prostatic urethra, the device applies an ultrasound-guided water jet that precisely ablates the prostate tissue. Aquablation therapy is unique in that it combines cystoscopic visualization, ultrasound imaging and advanced planning software to provide the surgeon with a multidimensional view of the treatment area. This enables personalized treatment planning for the patient's unique anatomy, improved decisionmaking and real-time monitoring during the procedure. This prospective single-arm investigational clinical trial aims at assessing the efficacy and safety of the new generation of the AQUABEAM Robotic System (P1G3) and the Apogee 2300 Ultrasound System and compare the percentage of patients who are discharged the day of the surgery among different groups of BPH patients who undergo aquablation using the third generation of the AQUABEAM Robotic System.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 30, 2024 |
Est. primary completion date | April 15, 2024 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - a) Patient has diagnosis of LUTS due to BPH - b) Patient is mentally capable and willing to sign a study-specific informed consent form - c) Patient is able and willing to follow study instructions and likely to attend and complete all required study visits Exclusion Criteria: - a) Patient is unable to stop anticoagulants, antiplatelet agents, or non-steroidal anti- inflammatory agents (NSAIDs, including aspirin greater or equal to 100mg) prior to treatment per standard of care - b) Contraindications for general and spinal anesthesia - c) Patient is unwilling to accept a blood transfusion if required |
Country | Name | City | State |
---|---|---|---|
Canada | Centre Hospitalier de l'université de Montréal (CHUM) | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Centre hospitalier de l'Université de Montréal (CHUM) | PROCEPT BioRobotics |
Canada,
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Monn MF, El Tayeb M, Bhojani N, Mellon MJ, Sloan JC, Boris RS, Lingeman JE. Predictors of Enucleation and Morcellation Time During Holmium Laser Enucleation of the Prostate. Urology. 2015 Aug;86(2):338-42. doi: 10.1016/j.urology.2015.04.028. Epub 2015 Jul 15. — View Citation
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TY - JOUR AU - Desai, Mihir AU - Bidair, Mo AU - Bhojani, Naeem AU - Trainer, Andrew AU - Arther, Andrew AU - Kramolowsky, Eugene AU - Doumanian, Leo AU - Elterman, Dean AU - Jr, Ronald AU - Lingeman, James AU - Krambeck, Amy AU - Eure, Gregg AU - Badlani
* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Percentage of study subjects who were discharged on the day of surgery | Percentage of study subjects who were discharged on the day of surgery (day case) in subjects = 80 years old with a prostate size =150cc , >150cc, and subjects >80 years old with any prostate size | Immediately after the surgery | |
Other | Post-op catheterization duration | Post-op catheterization duration will be calculated | 3 months | |
Other | Rate of readmissions within 1 week of discharge | Readmission within 1 week of discharge | 1 week | |
Other | Change in uroflow measurements from baseline to 3 month follow up visit | Change in uroflow measurements from baseline to 3 month follow up visit | 3 months | |
Other | Operation time | Operation time (TRUS in to catheter in) | During surgery | |
Primary | The change of the International Prostate Symptom Score (IPSS) from baseline to 3 months | The International Prostate Symptom Score (IPSS) change from baseline to 3 months will be compared to an objective performance criterion (OPC) based upon published TURP results of 16 points. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms. | 3 months | |
Primary | Rate of Unanticipated Serious Adverse Effect (USADE) | Unanticipated Serious Adverse Effect (USADE) rate observed up to the 3 months follow-up visit. | Immediately after the surgery | |
Secondary | Identification of the anatomical landmarks | The ability to provide adequate imaging for completing the surgical procedure as assessed by surgeons during the aquablation procedure | Immediately after the surgery |
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